INSTRUCTION MANUALSLIT LAMP

SL-D701

INTRODUCTIONThank you for purchasing the SLIT LAMP SL-D701.

INTENDED USE / INDICATIONS FOR USEThe Slit Lamp SL-D701 is an AC-powered slitlamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

FEATURESThis instrument has the following features:

• Various accessories to extend the system• Ergonomic cable layout• Clear fluorescent cornea observation and photography of cornea• Clear eyeground observation and photography by color conversion filter• Available with LED illumination or conventional halogen illumination

PURPOSE OF THIS MANUALTo get the best usage from the instrument, please read "DISPLAYS FOR SAFE USE" and "GENERAL SAFETY INFORMATION".Keep this Manual with the instrument for future reference.

1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permis-sion.

2. The contents of this manual are subject to change without prior notice and without legal obligation.3. The contents of this manual are correct to the best of our knowledge. Please inform us of any

ambiguous or erroneous descriptions, missing information, etc.4. Original Instructions.

This manual was originally written in English.

©2013 TOPCON CORPORATION ALL RIGHTS RESERVED

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GENERAL SAFETY INFORMATION

CONTRAINDICATION

This instrument must not be used for the following patients.• Patients who are hypersensitive to light• Patients who recently underwent photodynamic therapy (PDT)• Patients taking medication that causes photosensitivity

WARNING

Ensuring the Safety of Patients and OperatorsUse this instrument carefully on the following patients.• Patients who have epidemic corneitis, conjunctivitis or any other infectious disease.• Patients who are taking medications that cause light hypersensitivity

To avoid injury to the patient’s eye and nose, pay particular attention while operating the instrument body. (The patient may be injured.)The Topcon SL-D701 is a medical device. The software and hardware has been designed in accordance withU.S., European and other international medical device design and manufacturing standards. Unauthorized mod-ification of the Topcon SL-D701 software or hardware, or any addition or deletion of any application in any waycan jeopardize the safety of operators and patients, the performance of the instrument, and the integrity ofpatient data.Because prolonged intense light exposure can damage the retina, the use of the device for ocular examinationshould not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provideclear visualization of the target structures. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If thevalue of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit.While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recom-mended that the intensity of light directed into the patient's eye be limited to the minimum level which is neces-sary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also beincreased if the person being examined has had any exposure to the same instrument or any other ophthalmicinstrument using a visible light source during the previous 24 hours. This will apply particularly if the eye hasbeen exposed to retinal photography.Equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air, Oxygen, or NitrousOxide.The Topcon SL-D701 has no special protection against harmful ingress of water or other liquids (classified IPX0).To avoid damage to the instrument and cause a safety hazard, the cleaning solutions, including water, should notbe directly applied to the device. Using a dampened cloth (without dripping), is a good method to clean the exte-rior surface of the enclosure.Handling the cord on this product or cords associated with accessories sold with this product, will expose you tolead, a chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands after handling.

Preventing Electric Shocks and FiresTo avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " " and disconnect the power cord from the instrument if you see smoke coming from the instrument, etc. Don't install the instrument where it is difficult to disconnect the power cord from the instrument. Ask your dealer for service engineer.

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CAUTION

Ensuring the Safety of Patients and OperatorsBe careful not to let the patient touch this instrument. The patient's hand may be pinched by the movable part.To avoid burns caused by heat, do not replace the lamp with a new one immediately after it goes off.To avoid injury to the patient's head, incline the illumination unit slowly while holding the base unit.When operating the base unit, please note the following:

• Beware of catching fingers in the moving parts.• Avoid hitting the patient's eyes or nose.

Preventing Electric Shocks and FiresTo avoid injury or fire caused by electric shock, turn off the power switch and unplug the power cord when not in use.To avoid injury caused by electric shock, turn off the power switch when replacing the lamp.

Electromagnetic Compatibility (EMC)This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2 Ed.3.0: 2007as class B(classified according to CISPR11). This instrument radiates radio frequency energy within standard and may affect other devices in the vicinity.If you have discovered that turning on/off the instrument affects other devices, we recommend you change its position, keep a proper distance from other devices, or plug it into a different outlet.Please consult your authorized dealer if you have any additional questions.

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DISPLAYS AND SYMBOLS FOR SAFE USEIn order to ensure the safe use of the product and to prevent danger to the operator and others, or damage to prop-erty, important warnings are placed on the product and inserted in the instruction manual.It is recommended for all users to take note of the meaning of the following displays and icons before reading the "GENERAL SAFETY INFORMATION" and text.

DISPLAYS

SYMBOLS

Display Meaning

CONTRAINDICATION Situations in which the device should not be used because the risk of use clearly outweighs any possible benefit.

WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTESUseful functions to know. Paying attention to these willprevent the noted problems.

Symbol IEC/ISO Publication Description Description (French)IEC 60417-5032 Alternating Current Courant alternatif

IEC 60417-5008 Off (power: disconnection from the main power supply)

Éteint (courant: coupure avec le secteur)

IEC 60417-5007 On (power: connection to the main power supply)

Allumé (courant: raccordement sur le secteur)

IEC 60878-02-02 Type B applied part Partie appliquée du Type B

ISO 7010-W001 General warning sign Symbole d'avertissement général

ISO 7010-M002 Refer to instruction manual/booklet Voir le manuel/la brochure

ISO 7000-2497 Date of manufacture Date de fabrication

ISO 7000-2498 Serial number Numéro de série

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POSITIONS OF WARNING AND CAUTION INDICATIONSTo ensure safety, warning labels are provided on the instrument body.Use the instrument following these warning instructions. If any of the following labels are missing, contact your dealer or TOPCON (see the back cover).

No. Label Meaning Signification

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CAUTION・To prevent electric shocks, switch off

the power supply and remove thepower cable before replacing the lamp.

・Do not replace the lamp immediatelyafter switching it off: the high tem-peratures could cause burns.

PRÉCAUTION• Afin d’éviter les chocs électriques, cou-

pez l’alimentation électrique et débran-chez le câble d’alimentation avant deremplacer la lampe.

• Ne pas remplacer la lampe immédiate-ment après l’avoir éteinte: la températureélevée peut provoquer des brûlures.

2CAUTION

To avoid injury to the patient’s head,incline the illumination unit slowly whileholding the base unit.

PRÉCAUTIONAfin d’éviter de blesser le patient à la tête,inclinez lentement l’élément lumineux touten maintenant la base de l’appareil.

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When operating the base unit, pleasenote the following:・Beware of catching fingers in the 　moving parts.・Avoid hitting the patient’s eyes ornose.

PRÉCAUTIONLorsque vous maniez la base de l’appareil,veuillez noter les points suivants:• Faites attention à ne pas vous coincer les

doigts dans les parties en mouvement.• Évitez de heurter les yeux ou le nez du

patient.

4Degree of protection against electricshock: TYPE B APPLIED PART

Degré de protection contre les chocs élec-triques: TYPE B PARTIE D'APPLICATION

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MAINTENANCE

USER MAINTENANCE ITEMS

Item Inspection time ContentsInspection Before using • Adjusting the diopter and pupillary distance

• Focus of slit image• The base unit must move smoothly.• The components must be fitted in place correctly.• The chinrest unit must be fitted to the table unit correctly.• The cables and plugs must be connected correctly.• The objective lens, eyepiece and mirror must not be stained ordamaged.

Cleaning When the part is stained

• Objective lens• Eyepiece• Mirror• Sliding plate, rail and wheel shaft unit• Forehead rest and chinrest unit

Adjustment As required • Slit width control knob torque• Inclination torque of illumination unit

Replacement As required • Illumination lamp• Socket

Supply As required •Chinrest tissue

NOTE The following statement is the "Essential performance" provided for by IEC60601-1. The illumination light is not to be turned off.

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SPECIFICATIONS AND PERFORMANCESPECIFICATIONS

*1, *2 A model without exciter filter for slit lamp/barrier filter for slit lamp is also available.*3 A model without fixation target is also available.• The specification and design of the product can be altered for improvements without prior notice.

Microscope unitType Galileo typeMagnification Drum, 5-step magnificationMagnification steps 6/10/16/25/40

Overall magnification (actual vision field)

6.37 (φ35.1mm)9.94 (φ22.5mm)15.87 (φ14.1mm)25.37 (φ8.8mm)39.62 (φ5.6mm)

Eyepiece lens Magnification: 12.5xDiopter adjustment range: -5D to +5D

Binocular tubes PD adjustment: 55 to 78mm

Illumination unit

Illumination fieldSlit width: 0 to14mm, can be altered gradually(14mm=circle)Slit length: 14 to1mm, can be altered gradually(14mm=circle)Aperture diameter: φ14, 10, 5, 2, 1, 0.2

Slit directionVertical to horizontal, can be altered graduallyInclination: 5/10/15/20Side swing

Filter

Blue filter, red-free filter, amber filter, UV cut filter (normal use), IR cut filter (normal use), ND filter (13% transmission), exciter filter for slit lamp*1, barrierfilter for slit lamp*2

Illumination lamp Halogen type: 12V, 30WLED type: 3A, 10W

Base unitForward-backward movement 90mmRight-left movement 100mmVertical movement 30mmAmount of movement in all directions 12mm

Chinrest unitAmount of vertical movement of chinrest 80mm

Fixation target*3 Fixation target with diopter adjustmentLuminous fixation target

Fixation lamp LED (Red)

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Agency ComplianceThe SL-D701 is designed to comply with the following agency standards:• IEC 60601-1: 2005 Ed3.0• EN60601-1: 2006/AC:2010• IEC 60601-1-2 Ed3.0: 2007/EN60601-1-2:2007/AC:2010• AAMI/ANSI ES60601-1:2005/A32:2010• ISO 10939:2007• ISO 15004-1:2006• ISO 15004-2:2007• EC Medical Device Directive 93/42/EEC• CAN/CSA C22.2 No.60601-1:08

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GENERAL INFORMATION ON USAGE AND MAINTENANCEINTENDED PATIENT POPULATION

The patient who undergoes an examination by this instrument must maintain concentration for a few minutes and keep to the following instructions:

To fix the face to the chinrest, forehead rest.To keep the eye open.To understand and follow instructions when undergoing an examination.

INTENDED USER PROFILEThe SL-D701 SLIT LAMP is an electric instrument for medical use. Use this instrument under a doctor's guidance.

ENVIRONMENTAL CONDITIONS FOR USETemperature: 10°C to 40°CHumidity : 30% to 90% (without dew condensation)Air pressure : 700hPa to 1060hPa

STORAGE, USAGE PERIOD 1. Environmental conditions (without package)

*Temperature: 10°C to 40°C Humidity : 10% to 95% (without dew condensation) Air pressure : 700hPa to1060hPa*THIS INSTRUMENT DOES NOT MEET THE TEMPERATURE REQUIREMENTS OF ISO 15004-1 FOR STORAGE. DO NOT STORE THIS INSTRUMENT IN CONDITIONS WHERE THE TEMPERATURE MAY RISE ABOVE 40°C OR FALL BELOW 10°C.

2. When storing the instrument, ensure that the following conditions are met:(1)The instrument must not be splashed with water.(2)Do not store the instrument in an environment where air pressure, temperature, humidity, ventilation,

sunlight, dust, salty/sulfurous air, etc. could cause damage.(3)Do not store or transport the instrument on a slanted or uneven surface or in an area where it is subject

to vibrations or instability.(4)Do not store the instrument where chemicals are stored or gas is generated.

3. Normal life span of the instrument:8 years from delivery providing regular maintenance is performed (according to the self-certification [TOPCON data])

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGETemperature: -20°C to 50°CHumidity : 10% to 95%

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATIONTemperature: -40°C to 70°CHumidity : 10% to 95%

ELECTRIC RATINGSource voltage: AC100 - 240VFrequency : 50 - 60HzPower input : 110 VA

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DIMENSIONS AND WEIGHT

OPERATION PRINCIPLESIlluminates the observed part by the illumination light emitted from the illumination optical system and allows enlargement observation by binocular stereoscopic microscope.

DISPOSAL

When disposing the instrument and/or parts, follow the local regulations for disposal and recycling.

Dimensions, WeightDimensions: w/Table 550mm(W) x 399mm(D) x 760 to 790mm(H) w/ Unit Table 440mm(W) x 399mm(D) x 760 to 790mm(H) w/o Table 329mm(W) x 349mm(D) x 652 to 682mm(H) w/o Table and Chinrest 329mm(W) x 306mm(D) x 652 to 682mm(H)Weight: w/Table 19kg w/ Unit Table 18kg w/o Table 13kg w/o Table and Chinrest 11.5kgTable size 550mm x 370mmUnit Table size 440mm x 350mmHeight from the top to patient’s eye 375mm

CAUTION The base contains strong springs. Do not attempt to disassemble orburn the base, as the springs could cause injury by shooting out of it.

NOTES

This symbol is applicable for EU member countries only.To avoid potential damage to the environment and possibly human health, this instrument should be disposed of (i) for EU member countries - in accordance with WEEE (Directive on Waste Electrical and Electronic Equipment), or (ii) for all other countries, in accordance with local disposal and recycling laws.

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USAGE PURPOSE, FUNCTION AND EFFECTSThis instrument is used for the enlargement observation of eyeballs and the parts.

OPERATING AND USAGE METHODUsage method1. If required, use with the supplied accessories.2. Connect the power supply cord to a commercial power source.3. Turn ON the power switch.4. Adjust the diopter and pupillary distance(PD) of the microscope.5. Set the patient's head onto the chinrest.6. Set the magnification ratio.7. Move the base, set the focus and observe the patient's eye.8. If required, turn the brightness adjustment knob to set and change the illumination conditions.9. Turn OFF the power switch.

Please refer to the user manual.

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Please provide the following information when contacting us regarding questionsabout this instrument:• Model name: SL-D701• Serial No.: This is printed on the rating nameplate on the right side of the

power supply unit.• Period of use: Please inform us of the date of purchase.• Defective condition: Please provide us with as much detail as possible on the

problem.

SLIT LAMPSL-D701

INSTRUCTION MANUALThe 2013 version (2013.08-100TH )Date of issue: Sep 18, 2013

Published by TOPCON CORPORATION

75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.

©2013 TOPCON CORPORATION ALL RIGHTS RESERVED

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SLIT LAMP

SL-D701

44701 90910Printed in Japan 1309-100TH 0